Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.

Duke University

Status and phase: Completed; Phase 4

Conditions: Knee Extension; Primary Total Knee Arthroplasty; Pain; Knee Osteoarthritis; Physical Therapy

Treatments: Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block; Drug: Saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03353233

Pro00070573

Details and patient eligibility

About

The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking
• Between 18 and 75 years old
• American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty

Exclusion criteria

• ASA 4 or 5
• Revision knee arthroplasty
• Diagnosis of chronic pain
• Daily chronic opioid use (over 3 months of continuous opioid use)
• Inability to communicate pain scores or need for analgesia
• Acute knee dislocation/fracture
• Infection at the site of block placement
• Age under 18 years old or greater than 75 years old
• Pregnant women
• Intolerance/allergy to local anesthetics
• Weight <50 kg
• Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
• Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

iPACK Block Group

Experimental group

Description:

A nerve block technique using a numbing medication called ropivacaine.

Treatment:

Drug: Ropivacaine

Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block

Sham Group

Placebo Comparator group

Description:

The same nerve block technique as above, however using an inactive solution of salt water.

Treatment:

Drug: Saline

Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block